Caldera Launches with USD 112.5m Series A, Puts IL-23p19 / TL1A BsAb into Phase 1

US-based biotech Caldera Therapeutics announced its launch with the finalization of a USD 112.5 million Series A funding round, set to focus on the development of innovative immunology therapies. In addition, the firm announced first patient dosing in a Phase 1 trial for its lead pipeline candidate CLD-423, a bispecific antibody (BsAb) under development for inflammatory bowel disease (IBD).

The funding round was led by founding investors Atlas Venture, LAV, and venBio, and included a recently completed USD 37.5 million Series A-1 extension led by Omega Funds with participation from Wellington Management and Janus Henderson Investors. Proceeds will support ongoing clinical development of CLD-423 and broader company operations.

CLD-423 is a first-in-class bispecific antibody designed to simultaneously engage the clinically validated IL-23p19 and TL1A pathways, which are implicated in the pathogenesis of IBD including ulcerative colitis and Crohn’s disease. The dual-target approach aims to enhance therapeutic efficacy and overcome limitations observed with single-target biologics.

The program was licensed from Qyuns Therapeutics in April 2025, when Caldera secured exclusive global rights to develop and commercialize the asset, originally known as QX030N. Under the terms of the deal, Qyuns received a USD 10 million upfront payment and took a 24.88 % equity stake in Caldera. The agreement also includes up to approximately USD 545 million in potential development, regulatory and commercial milestone payments, as well as tiered royalties on future sales.

Qyuns has already received a USD 5 million milestone payment tied to regulatory approval to begin the Phase 1 trial in Australia, marking the first clinical trigger under the partnership.

Caldera said first healthy volunteers have now been dosed in the Phase 1 study, which is assessing safety, tolerability and pharmacokinetics ahead of planned trials in patients with IBD. Notably, Caldera is vying with Xencor Inc., which is planning to put an IL-23p19 / TL1A-targeted BsAb into Phase 1 trials as a potential IBD treatment later this year.